CLASS III Drug recall · Reported 19 Sep 2018 · FDA Enforcement Report
Tyvaso Inhalation System Patient a) Starter Kit with Tyvaso recalled
United Therapeutics is recalling Tyvaso Inhalation System Patient a) Starter Kit with Tyvaso (treprostinil) Inhalation, distributed in Illinois, Pennsylvania. The recall was initiated on 14 Aug 2018 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1188-2018
- FDA event ID
- 80834
- Recalling firm
- United Therapeutics, Durham, NC
- Brand
- Tyvaso
- Manufacturer
- United Therapeutics Corporation
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 14 Aug 2018
- FDA classified
- 12 Sep 2018
- Reported
- 19 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 14 Aug 2018 | Recall initiated by company | |
| 12 Sep 2018 | Classified by FDA | +29 days |
| 19 Sep 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Product as listed by the FDA
Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) (NDC 66302-206-01) b) TD-300/A Replacement Device Kit Material Number RTP3099 RX Only. Manufactured by United Therapeutics Corporation Research Triangle Park, NC 27709
Where it was distributed
IL, PA
Questions about this recall
Why was it recalled?
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Which lots are affected?
Lot number a) 2101503, 2101507, 2101523, 2101532, 2101533, EXP 07/31/2019; 2101557, EXP 11/30/2019 b) Lot # 2101504, EXP 4/24/2021; 2101509, 2101522, EXP 5/8/2021; 2101531, EXP 5/15/2021; 2101534, EXP 6/10/2021; 2101543, EXP 6/14/2021; 2101558, EXP 7/26/2021
Where was it sold?
IL, PA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from United Therapeutics
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tyvaso (treprostinil) Inhalation Solution Treprostinil recalled | United Therapeutics | Manufacturing (CGMP) Deviations | PA |
| Drug | CLASS II | Tyvaso (treprostinil) Inhalation Solution recalled | United Therapeutics | Other | TX |
Other Treprostinil recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Treprostinil Injection, 20 mg/ (1 mg/mL) recalled | Par Sterile Products | Particulate Matter | Nationwide |